Patient Recruitment
Patient Pre-screening
Patient pre-screening is the process of evaluating individuals against a clinical trial's inclusion and exclusion criteria, before formal screening visits, to identify likely-eligible candidates and reduce screen failure rates.
Pre-screening separates the small subset of likely-eligible patients from the much larger pool of theoretically interested ones. Done well, it dramatically lowers the per-randomized-patient cost; done poorly, it produces the industry-standard ~30; 50% screen failure rate that wastes site time and burns recruitment budget.
Manual pre-screening means a coordinator reads physician notes, lab values, imaging reports, and medication lists for each potential participant. AI-powered pre-screening (Kitsa KScreener and similar tools) ingests structured and unstructured EHR data via FHIR, applies the protocol's criteria as code, and returns a ranked patient list with the supporting evidence quoted from each chart, so coordinators only review high-probability matches.
Patient pre-screening is governed by HIPAA in the United States and GDPR Article 9 in the EU; both require either patient authorization or a covered preparatory-to-research basis to access PHI for eligibility evaluation.
Related terms
Screen Failure Rate
The screen failure rate is the percentage of patients who consent to be screened for a clinical trial but are subsequently found ineligible and not randomized.
Inclusion / Exclusion Criteria
Inclusion and exclusion criteria are the protocol-defined conditions a person must satisfy (inclusion) or not exhibit (exclusion) to be eligible to enroll in a clinical trial.
FHIR (Fast Healthcare Interoperability Resources)
FHIR is the HL7-published standard, expressed as a RESTful API and resource-based data model, that enables interoperable exchange of structured healthcare data between EHRs, payers, registries, research systems, and patient applications.
EHR Integration (for Clinical Trials)
EHR integration in clinical research is the secure, standards-based connection between an electronic health record system and a clinical-trial application that enables eligibility screening, data abstraction, and source-data verification without manual transcription.
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